Inspections, Compliance, Enforcement, and Criminal Investigations
[Federal Register: January 11, 1995 (Volume 60, Number 7)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0285]
Andrew Morris; Debarment Order
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Mr. Andrew Morris, 5731 Laurel Hill Dr., Indianapolis, IN 46226, from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Morris was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product; and relating to the regulation of a drug product under the act. Mr. Morris has notified FDA that he acquiesces to debarment and, therefore, has waived his opportunity for a hearing concerning this action.
EFFECTIVE DATE: May 16, 1994.
ADDRESSES: Application for termination of debarment to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Tamar S. Nordenberg, Center for Drug Evaluation and Research (HFD-366), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-2041.
Mr. Andrew Morris, a former employee at Quad Pharmaceuticals, Inc. (Quad), first as a bench chemist and later as a manager in Quad's research and development department, pled guilty and was sentenced on May 13, 1994, for making a false statement to a U.S. Government agency, a Federal felony under 18 U.S.C. 1001, and for obstructing an agency proceeding, a Federal felony under 18 U.S.C. 1505. The basis for this conviction was as follows:
- False Statement to a Federal Agency
Mr. Morris, while working as a bench chemist at Quad, made a false representation in a certificate of analysis regarding the potency of a particular lot of the drug azathioprine sodium, which was submitted to FDA in support of an abbreviated new drug application (ANDA) for the drug.
- Obstruction of an Agency Proceeding
During an FDA audit of Quad's research and development department, Mr. Morris gathered and destroyed certain nonsterile samples of colistimethate sodium. These samples had previously been represented to FDA as sterile in batch production records. These records were prepared under Mr. Morris' supervision and were included in the ANDA for the drug product.
Mr. Morris is subject to debarment based on a finding, under section 306(a)(2) of the act (21 U.S.C. 335a(a)(2)), that he was convicted of felonies under Federal law for conduct relating to the development, approval, and regulation of a drug product. Mr. Morris' false statements in documents used to support the ANDA's for the two Quad drug products relate to the development or approval of a drug product because FDA relies on the safety and efficacy data and information in the ANDA's in making its decisions whether to approve drug products. Mr. Morris' false statements and destruction of drug samples relate to the regulation of drug products because FDA's regulatory decisions about Quad drug products may have been affected by the conduct.
In a letter received by FDA on May 16, 1994, Mr. Morris notified FDA of his acquiescence to debarment, as provided for in section 306(c)(2)(B) of the act. A person subject to debarment is entitled to an opportunity for an agency hearing on disputed issues of material fact under section 306(i) of the act, but by acquiescing to debarment, Mr. Morris waived his opportunity for a hearing and any contentions concerning his debarment.
- False Statement to a Federal Agency
- Findings and Order
Therefore, the Interim Deputy Commissioner for Operations, under section 306(a) of the act, and under authority delegated to her (21 CFR 5.20), finds that Mr. Andrew Morris has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product (21 U.S.C. 335a(a)(2)(A)); and relating to the regulation of a drug product (21 U.S.C. 335a(a)(2)(B)).
As a result of the foregoing findings and based on his notification of acquiescence, Mr. Andrew Morris is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under section 505, 507, 512, or 802 of the act (21 U.S.C. 355, 357, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective May 16, 1994, the date of notification of acquiescence (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 21 U.S.C. 321(ee)). Any person with an approved or pending drug product application who knowingly uses the services of Mr. Morris, in any capacity, during his period of debarment, will be subject to civil money penalties. If Mr. Morris, during his period of debarment, provides services in any capacity to a person with an approved or pending drug product application, he will be subject to civil money penalties. In addition, FDA will not accept or review any ANDA's submitted by or with the assistance of Mr. Morris during his period of debarment.
Any application by Mr. Morris for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. 94N- 0285 and sent to the Dockets Management Branch (address above). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: January 4, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-695 Filed 1-10-95; 8:45 am]
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